NCT02255474

Brief Summary

This study will evaluate the use of two different bifocal contact lens add powers to prevent further nearsighted progression in children ages 7 to 11 years old. It is theorized that the profile of the bifocal lenses will decrease the amount of change in nearsightedness that the children experience.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2019

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 10, 2021

Completed
Last Updated

March 10, 2021

Status Verified

February 1, 2021

Enrollment Period

4.8 years

First QC Date

September 23, 2014

Results QC Date

June 24, 2020

Last Update Submit

February 17, 2021

Conditions

Refractive Errors

Keywords

pediatricsrefractive error - myopiacontact lensesintervention

Outcome Measures

Primary Outcomes (1)

  • Refractive Error Progression

    Refractive error, as measured by cycloplegic autorefraction in both eyes, will be measured yearly to assess the difference in progression between the two soft bifocal treatment lenses (+1.50 D add and +2.50 D add) and the control group (soft spherical contact lenses).

    3 years

Secondary Outcomes (3)

  • Ocular Shape Change and Eye Growth

    3 years

  • Association of Peripheral Defocus to Myopic Progression

    3 years

  • Axial Length Progression

    3 years

Study Arms (3)

Biofinity

ACTIVE COMPARATOR

Soft spherical contact lens

Device: Biofinity

Biofinity Multifocal D +1.50 add

EXPERIMENTAL

The Biofinity Multifocal "D" with a +1.50 add is a soft bifocal contact lens that has a medium reading power

Device: Biofinity Multifocal D +1.50 add

Biofinity Multifocal D +2.50 add

EXPERIMENTAL

The Biofinity Multifocal "D" with a +2.50 add is a soft bifocal contact lens that has a strong reading power

Device: Biofinity Multifocal D +2.50 add

Interventions

Biofinity Multifocal D +1.50 addDEVICE

This is a monthly disposable contact lens commercially available from CooperVision

Biofinity Multifocal D +1.50 add
Biofinity Multifocal D +2.50 addDEVICE

This is a monthly disposable contact lens commercially available from CooperVision

Biofinity Multifocal D +2.50 add
BiofinityDEVICE

This is a monthly disposable spherical contact lens commercially available from CooperVision

Biofinity

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • to 11 years, inclusive, at baseline examination
  • to -5.00 D, inclusive, spherical component, cycloplegic autorefraction
  • ≤1.00 DC, cycloplegic autorefraction
  • ≥ 2.00 D difference between the sphere components of the two eyes (anisometropia), cycloplegic autorefraction
  • logMAR or better best-corrected visual acuity in each eye
  • logMAR or better visual acuity OU distance and near with a +2.50 D add contact lens
  • +2.50 D add lens provides adequate fit with respect to movement and centration

You may not qualify if:

  • Eye disease or binocular vision problems (e.g., strabismus, amblyopia, oculomotor nerve palsies, corneal disease, etc.)
  • Systemic disease that may affect vision, vision development, or contact lens wear (eg, diabetes, Down syndrome, etc.)
  • Previous gas permeable, soft bifocal, or orthokeratology contact lens wear or bifocal/PAL spectacle wear (longer than 1 month of wear)
  • Previous or current participation in myopia control studies
  • Chronic use of medications that may affect immunity, such as oral or ophthalmic corticosteroids for ocular or systemic diseases
  • Issues that may interfere with the ability to participate over the next 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

University of Houston College of Optometry

Houston, Texas, 77204, United States

Location

Related Publications (5)

  • Chandler MA, Robich ML, Jordan LA, Mutti DO, Berntsen DA, Fenton R, Day E, Walline JJ; BLINK2 Study Group. Accommodation in Children after 4.7 Years of Multifocal Contact Lens Wear in the BLINK Study Randomized Clinical Trial. Optom Vis Sci. 2023 Jul 1;100(7):425-431. doi: 10.1097/OPX.0000000000002040. Epub 2023 Jun 24.

    PMID: 37369096DERIVED

  • Gaume Giannoni A, Robich M, Berntsen DA, Jones-Jordan LA, Mutti DO, Myers J, Shaw K, Walker MK, Walline JJ; BLINK Study Group. Ocular and Nonocular Adverse Events during 3 Years of Soft Contact Lens Wear in Children. Optom Vis Sci. 2022 Jun 1;99(6):505-512. doi: 10.1097/OPX.0000000000001902. Epub 2022 Apr 12.

    PMID: 35413027DERIVED

  • Walline JJ, Walker MK, Mutti DO, Jones-Jordan LA, Sinnott LT, Giannoni AG, Bickle KM, Schulle KL, Nixon A, Pierce GE, Berntsen DA; BLINK Study Group. Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial. JAMA. 2020 Aug 11;324(6):571-580. doi: 10.1001/jama.2020.10834.

    PMID: 32780139DERIVED

  • Schulle KL, Berntsen DA, Sinnott LT, Bickle KM, Gostovic AT, Pierce GE, Jones-Jordan LA, Mutti DO, Walline JJ; Bifocal Lenses in Nearsighted Kids (BLINK) Study Group. Visual Acuity and Over-refraction in Myopic Children Fitted with Soft Multifocal Contact Lenses. Optom Vis Sci. 2018 Apr;95(4):292-298. doi: 10.1097/OPX.0000000000001207.

    PMID: 29561497DERIVED

  • Walline JJ, Gaume Giannoni A, Sinnott LT, Chandler MA, Huang J, Mutti DO, Jones-Jordan LA, Berntsen DA; BLINK Study Group. A Randomized Trial of Soft Multifocal Contact Lenses for Myopia Control: Baseline Data and Methods. Optom Vis Sci. 2017 Sep;94(9):856-866. doi: 10.1097/OPX.0000000000001106.

    PMID: 28737608DERIVED

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Dr. Jeffrey Walline
Organization
The Ohio State University
walline.1@osu.edu
614-247-6840

Study Officials

  • Jeffrey Walline, OD, PhD

    Ohio State University

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 23, 2014

First Posted

October 2, 2014

Study Start

September 22, 2014

Primary Completion

June 24, 2019

Study Completion

June 24, 2019

Last Updated

March 10, 2021

Results First Posted

March 10, 2021

Record last verified: 2021-02

Locations

US(2)